(351 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, image processing, or any other indicators of AI/ML technology. The description focuses solely on the intended use and anatomical site.
Yes
The device is described as being used for "Temporary occlusion of intracranial blood verssels/aneurysms" and "Permanent placement in the brain for occlusion of aneurysms," which are therapeutic interventions.
No
The device's intended use is for "Temporary occlusion of intracranial blood verssels/aneurysms" and "Permanent placement in the brain for occlusion of aneurysms," which describes a therapeutic or interventional function, not a diagnostic one.
No
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use suggests a physical implant or device for occlusion, which is typically hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Temporary occlusion of intracranial blood vessels/aneurysms" and "Permanent placement in the brain for occlusion of aneurysms." This describes a device that is physically placed within the body to treat a condition.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The description clearly indicates a device that is implanted or used directly within the patient's body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Temporary occlusion of intracranial blood verssels/aneurysms.
Permanent placement in the brain for occlusion of aneurysms.
Product codes
HCH, HCI
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Intracranial blood verssels/aneurysms, brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.
NOV 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pacific Surgical Innovations, Inc. % Mr. Terry Johnston President 360 Industrial Road, Unit H San Carlos, California 94070
Re: K972750
Trade/Device Name: Taka Aneurysm Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH, HCI Dated: June 8, 1998 Received: June 15, 1998
Dear Mr. Johnston:
This letter corrects our substantially equivalent letter of July 9, 1998.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or fo devices that have been reclassified in accordance with the provisions of the Federal Foend. Orug and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). 701 may, therefore, market the device, subject to the general controls provisions of the Act. The goneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, PTDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the eestronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000- 050.
1
Page 2 - Mr. Terry Johnston
This letter will allow you to continue marketing your device as described in your Section 510(k) I mis lotter will anon yourse FDA finding of substantial equivalence of your device to a legally premailer notificated on " results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you doon o office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely you
for Pts. Thoms Das Dastgul
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 5
INDICATIONS FOR USE
510(K) Number:
Device Name:
Taka (Tm) Aneurysm Clip
Indications for Use:
Temporary occlusion of intracranial blood verssels/aneurysms.
Permanent placement in the brain for occlusion of aneurysms.
rdiovascular, Respiratory, rological Devices 972750
Prescription Use
OR
Over the Counter _____________________________________________________________________________________________________________________________________________________________